On November 22, 2023, AstraZeneca announced Andasut®(General Name: Dapagliflozin Metformin Sustained-Release Tablets), this combination drug for type 2 diabetes, has officially been launched in China. Professor Linong Ji from Peking University People's Hospital, Professor Dalong Zhu from Nanjing Drum Tower Hospital, and Professor Dajin Zou from Tongren Hospital affiliated with Shanghai Jiao Tong University School of Medicine, along with many other interdisciplinary experts and scholars in China, attended this grand event to jointly witness the arrival of another innovative new drug in the field of diabetes.
Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets are a combination drug that incorporates two anti-hyperglycemic agents with complementary mechanisms of action: dapagliflozin (brand name: Forxiga), a sodium-glucose co-transporter-2 (SGLT2) inhibitor, which has previously been approved in China for the treatment of adult type 2 diabetes, symptomatic chronic heart failure, and chronic kidney disease, and metformin hydrochloride extended-release tablets, an oral biguanide taken once daily. As the only fixed-dose combination therapy in China that combines an SGLT2 inhibitor with extended-release metformin hydrochloride in a single daily dose, Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets provide a first-line treatment option to improve glycemic control in patients with type 2 diabetes.
High Sugar Harms the Heart and Kidneys, Controlling Sugar Protects the Heart and Kidneys Equally
The Number of Diabetes Patients in China is Approximately 129 Million1, of which type 2 diabetes accounts for more than 90% of the entire diabetic population.2. However, the situation of diabetes prevention and treatment is not optimistic. Data shows that many patients with type 2 diabetes have poor blood glucose control, and 60% of patients' blood glucose levels are not within the target range.3On the other hand, the biggest problem faced by diabetic patients in clinical practice is cardiorenal complications. Diabetes is an independent risk factor for cardiovascular and cerebrovascular diseases.4Compared with non-diabetic populations, the risk of cardiovascular and cerebrovascular diseases in diabetic patients increases by 2 to 4 times, and about 80% of diabetic patients eventually die from cardiovascular events.4. In addition, about one-third of diabetes cases are associated with kidney disease.5，30%-50% of kidney failure is caused by diabetes.6, requiring kidney transplantation or long-term dialysis.
"The Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)" points out that the short-term goal of diabetes treatment is to eliminate diabetes symptoms and prevent acute complications by controlling hyperglycemia and metabolic disorders, while the long-term goal is to achieve the purpose of preventing cardiovascular and renal complications, improving patients' quality of life, and prolonging life expectancy through good metabolic control.
Dual Mechanisms Combine for Multiple Patient Protections
Professor Ji Linong stated: "The strategy and concept of treating and managing type 2 diabetes, which emphasizes both glycemic control and the improvement of cardiovascular and renal outcomes, have increasingly resonated with medical professionals. The treatment model now comprehensively considers achieving glycemic targets alongside cardiovascular and renal protection, ensuring 'early treatment, early target achievement, and early protection.' The arrival of dapagliflozin metformin sustained-release tablets provides a new therapeutic approach offering 'one solution, dual protection' for achieving both short-term and long-term goals in diabetes treatment."
At the same time, medication adherence is crucial for disease management in patients with diabetes, and factors affecting medication adherence include the convenience of taking medication. Currently, more than half of patients with type 2 diabetes need to take 3-6 tablets per day.8Studies have shown that patients using only one oral hypoglycemic agent have 45% higher medication adherence over a continuous one-year period compared to those using two drugs simultaneously.9。
Professor Zou Dajin pointed out: "As a compound preparation, dapagliflozin metformin sustained-release tablets have two complementary mechanisms of action, which also help to simplify the treatment regimen, better improve patient compliance, and help patients achieve blood glucose control and cardio-renal protection."
AstraZeneca China General Manager Leon Lai Ming-lung stated: "Improving blood glucose control rates and reducing cardiovascular and renal complications are critical tasks in China's diabetes prevention and treatment, as well as unmet needs of patients. Over the past thirty years since AstraZeneca entered China, we have always adhered to the concept of 'patient-centeredness,' deeply understood patient needs, and continuously developed and introduced innovative drugs with the aim of bringing comprehensive benefits to patients. We hope that the accelerated application of dapagliflozin metformin sustained-release tablets in China will allow patients to soon have a simplified treatment option that achieves blood sugar control while protecting the heart and kidneys, improving prognosis and quality of life in multiple ways."
About Type 2 Diabetes
Type 2 diabetes is a chronic disease characterized by pathophysiological defects leading to elevated glucose levels or hyperglycemia.7. Over time, persistent hyperglycemia will lead to the further progression of the disease.7It is estimated that by 2045, the number of people with diabetes will reach 783 million.7In China, type 2 diabetes accounts for more than 90% of the entire diabetic population.2Many patients have poor blood glucose control, low medication adherence, and there remains a significant unmet medical need.7,8
About Dapagliflozin Metformin Sustained-Release Tablets
Dagliflozin Metformin Sustained-Release Tablets are the first compound formulation combining dagliflozin (SGLT2 inhibitor) and metformin sustained-release agent (biguanide), taken once daily, in conjunction with diet control and exercise. It is suitable for adult patients with type 2 diabetes who are appropriate candidates for treatment with both dagliflozin and metformin hydrochloride to improve glycemic control.
About Dapagliflozin
Dapagliflozin is the first-in-class sodium-glucose cotransporter-2 (SGLT2) inhibitor, taken orally once daily. As scientific research continues to uncover potential links between the heart, kidneys, and pancreas, studies have also demonstrated the efficacy of dapagliflozin in slowing cardiorenal disease progression and providing organ protection.10-12. Damage to a single organ can lead to dysfunction in other organs, which is also a major cause of death worldwide, including conditions such as type 2 diabetes, heart failure, and chronic kidney disease (CKD).13-15。
*As of November 2023
References:
1. Li Y, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ. 2020; 369-997.
2. Weng J, et al. Standards of care for type 2 diabetes in China. Diabetes Metab Res Rev. 2016 ;32(5):442-58.
3. Yu Xu, et al. Prevalence and Control of Diabetes in Chinese Adults. JAMA. 2013;310(9):948-958.
4. Wang Weiqing. Guidelines for Metabolic Disease Management of the National Standardized Metabolic Diseases Management Center (MMC) (2nd Edition)[J]. Chinese Journal of Endocrinology and Metabolism, 2023, 39(06): 538-554.
5. Chinese Diabetes Society of the Chinese Medical Association. Chinese Journal of Diabetes. 2018,10(1):4-67
6. Tuttle KR, Bakris GL,Bilous RW, et al. Diabetic kidney disease: a report from an ADA Consen-sus Conference. Diabetes Care 2014;37:2864-2883
7. International Diabetes Federation [Internet]. IDF Diabetes Atlas Tenth Edition 2021. [cited 2023 June 20]. Available from: https://diabetesatlas.org/idfawp/resource-files/2021/07/IDF_Atlas_10th_Edition_2021.pdf
8. Blüher M, et al. Pill Burden in Patients With Type 2 Diabetes in Germany: Subanalysis From the Prospective, Noninterventional PROVIL Study. 2015; 33(2): 55–61.
9. Dailey G, Kim MS, Lian JF. Patient compliance and persistence with anti-hyperglycemic therapy: evaluation of a population of type 2 diabetic patients[J].J Int Med Res,2002,30(1);71-79.
10. McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995–2008.
11. Heerspink HJL, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020;383(15):1436-1446.
12. Wiviott SD, et al; for the DECLARE-TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes [article and supplementary appendix]. N Engl J Med. 2019;380(4):347-357.
13. Mayo Clinic [Internet]. Heart failure [cited 2023 June 20]. Available from: https://www.mayoclinic.org/diseases-conditions/heart-failure/symptoms-causes/syc-20373142.
14. Centers for Disease Control and Prevention (CDC) [Internet]. A snapshot: Diabetes in the United States [cited 2023 June 20]. Available from: https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html.
15. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) [Internet]. Heart disease & kidney disease [cited 2023 June 20]. Available from: https://www.niddk.nih.gov/health-information/kidney-disease/heart-disease.
